Useful in the clinic. Defensible in the audit.
In MedTech and life sciences, software has to do more than work. It has to be specified, tested, traceable and kept under control after release, often inside a quality system that was designed before AI existed.
We bring hands-on engineering and long experience of regulated environments to teams building AI tools, clinical and operational software, and the data connections behind them.
[ + ]THE CHALLENGE
AI behaves differently from the software your quality system expects.
Traditional validation assumes the same input gives the same output. AI models don't always oblige, and they can drift as data changes. Health data carries extra protection under GDPR, and the line between a useful tool and a regulated medical device depends on intended purpose. The result is that many good ideas stall between pilot and production.
[ + ]WHERE WE HELP
- /01
Use cases weighed against the validation and data burden they bring, before anyone writes code.
- /02
Applications for clinicians, patients, field and quality teams, with requirements and changes traced.
- /03
Test, CAPA, service and product records made usable by reporting and AI tools, with access controlled.
- /04
Evaluation datasets, monitoring, human review and audit trails that hold up in a quality review.
- /05
Service tickets, calls and CRM notes pulled into themes a product team can act on.
[ + ]UNDERSTAND THE OBLIGATIONS, THEN BUILD TO THEM
Agreed requirements, translated into engineering controls and evidence.
Depending on the product and its intended purpose, teams may need to consider the EU MDR or IVDR, IEC 62304 for the software lifecycle, ISO 13485 and ISO 14971, GDPR for health data, computer system validation and the EU AI Act. Whether software counts as a medical device is a regulatory judgement that belongs with your regulatory affairs team and advisers. We help turn the agreed requirements into engineering controls and the records to show them.
[ + ]REGULATED DELIVERY
We have built and run software under a regulator's eye.
Our founder has spent twenty years at CTO and CIO level across financial services and MedTech. We have worked with multiple ISO 13485 compliant companies. Medical regulation differs in detail, but the habits carry over: written requirements, controlled change, tested releases and evidence kept as the work happens.
[ + ]FUNDING
Public funding may cover part of the first step.
Irish MedTech and life sciences companies can sometimes use Enterprise Ireland supports for discovery, feasibility and innovation work. We help shape the project for a funding discussion and work with your Development Adviser where that helps. Eligibility and approval rest with the agency.
US
Build it so it can be validated.
Tell us what you want to build and the quality system it has to fit into. We'll help you work out a sensible first step.